FDA shifts regulatory requirements for intra-aortic balloons

FDA lowers regulatory barriers for certain intra-aortic balloons and asks for premarket approval applications and product development protocols for others.

The FDA issued a final rule reclassifying certain intra-aortic balloons and demanding more from others, according to a notice in the Federal Register.

The new rule eases regulation on intra-aortic balloons and pumps indicated for acute coronary syndrome, cardiac and non-cardiac surgery or complications of heart failure, lowering their classification from Class III to Class II.